Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor.

Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor.

The patents lack inventive step over Battung and Zadok because the claimed swallowable film-coated deferasirox tablets with specified excipients and 45-60% drug loading would have been obvious to the skilled team at the priority date. The inventive concept does not include increased bioavailability or reduced food effect, as these are not features of the claims. Teva DFX does not infringe the patents, either literally or by equivalence, because its deferasirox content is outside the claimed range, and strict compliance with the range is required by the inventive concept as understood by the skilled person.

Parties
Claimant: Teva Pharmaceutical Industries Limited; Claimant: Teva UK Limited; Defendant: Novartis AG; Defendant: Novartis Pharmaceuticals UK Limited
Jurisdiction
England and Wales
Judgment Date
10 November 2022
Procedural Posture
Patent Revocation and Declaration of Non Infringement / Judgment After Trial
Outcome
Patents held invalid for lack of inventive step; declaration of non-infringement granted; all proposed amendments refused.
Legal Topics
Inventive Step, Obviousness, Patent Infringement, Doctrine of Equivalents, Patent Amendment, Sufficiency, Double Patenting
Intellectual Property Patent Law Inventive Step Obviousness Patent Infringement Doctrine of Equivalents Patent Amendment Sufficiency +1 more

Case Brief

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Parties

Teva Pharmaceutical Industries Limited

Claimant

Teva UK Limited

Claimant

Novartis AG

Defendant

Novartis Pharmaceuticals UK Limited

Defendant

Procedural Posture

Patent Revocation and Declaration of Non Infringement / Judgment After Trial

Legal Issues

  1. 1 Whether the patents in suit lack inventive step over the cited prior art
  2. 2 Whether the patents are invalid for insufficiency or arbitrary selection
  3. 3 Whether Teva DFX infringes the patents, including by equivalence

Ratio Decidendi

The patents lack inventive step over Battung and Zadok because the claimed swallowable film-coated deferasirox tablets with specified excipients and 45-60% drug loading would have been obvious to the skilled team at the priority date. The inventive concept does not include increased bioavailability or reduced food effect, as these are not features of the claims. Teva DFX does not infringe the patents, either literally or by equivalence, because its deferasirox content is outside the claimed range, and strict compliance with the range is required by the inventive concept as understood by the skilled person.

Court Disposition

Patents held invalid for lack of inventive step; declaration of non-infringement granted; all proposed amendments refused.

Orders

  • Claims 1 and 2 of EP 202 and EP 018 are invalid for lack of inventive step over Battung and Zadok.
  • All proposed amendments to the patents are refused.